CN105034360B - Integrated more material implantation pieces and manufacturing method - Google Patents

Abstract

Here provide for manufacturing the method and system of more material bodies in a manner of successively, which can be that bone stablizes implantation piece.More material bodies include rigidity and flexible portion, and the rigidity and flexible portion are formed integrally with each other.More material bodies can be softened or hardened in special area, so that the biology or anatomical features with bone match.

Description

Integrated more material implantation pieces and manufacturing method

Divisional application

The application is divisional application, and the Application No. 201080059343.5 of original application, the applying date is December 28 in 2010 Day, entitled " integrated more material implantation pieces and manufacturing method ".

Cross reference to related applications

This application claims the priority of U.S. Patent application No.61/291126, U.S. Patent application No.61/291126 Entitled " Integrated Multi-Material Implant and Method of Manufacture ", the applying date For on December 30th, 2009, actually the entire disclosure of which was added in by quoting herein.

Technical field

The present invention relates to more material implantation pieces, the method for further relating to belong to the additional manufacture of more material implantation pieces.

Background technology

Common bone connection implantation piece, plate and associated components for bone fixation are usually by metal, polymer, heterologous, of the same race Allogeneic or other materials are designed and manufactured, these materials are integrally formed into single piece of raw material.Bone connects implantation piece Size and shape generally according to the bone to be repaired biomechanical characterization and pass through determine bone connect implantation piece size and profit Bone connection implantation piece is fixed on bone to design with the device of suitable dimension.

Some bones connection implantation piece is designed to there is multiple components, for example, the plate with screw or with lock screw or The intramedullary nail of other locking mechanisms.Bone connection implantation piece can include multiple components, so as to align fracture segment and/or alignment Adjacent bone.But, most of component of bone connection implantation piece（Such as plate, nail or screw）It is designed and is made by single piece of raw material It makes, this may limit the control of the mechanical elasticity to subsequent bone connection implantation piece and associated components.Therefore, it is intended that form this The bone connection implantation piece and component of sample so that their material property is as close possible to the biomechanics characteristic of the bone to be repaired.

Bone of the theoretical explanations of Wolff in healthy human or animal body is used to carry the load suffered by it.Therefore, bone is in height It is grown in load area, and re-absorption or refigure in low-load region.It is too hard when repairing fracture or connection bone Bone connection implantation piece generates the danger of bone resorption, because excessive load leaves bone and passes to bone connection implantation piece.With compared with The bone connection implantation piece of soft may cause fracture that cannot heal due to excessive movements or the implantation piece fracture in fracture.

Include for connecting implantation piece by bone come internal fixed important biomolecule terms of mechanics to the firm of bone structure Main fixation and the complex biological mechanical property for union.It connects or twists at it for example, it may be desirable to which bone connects implantation piece It is harder and relatively strong at position in the marrow, but have more soft or elastic feature in the part across fracture, more to connect The characteristic of near-earth analog bone and can be by the fracture area of reconnect come carry load.

In general, main fixation is realized using pin, screw, nail, porous surface, spike or riveting fixed mechanism.Connection implantation The inside of plate and nail as fracture segment of part is fixed and registration mechanism.By the way that bone connection implantation piece is designed to change material, is cut Face, opening and other feature, implantation piece can provide fracture special rigidity and stability.

May want to manufacture has the Composite Bone connection implantation piece of combination of materials in the same parts of implantation piece.When they with The bone of connection or the biomechanical characterization in fixed joint mutual added time, the value of these implantation pieces improve.

The content of the invention

A kind of method for manufacturing component is provided in the first embodiment, and this method includes：So that the curable powder of first layer End is deposited on platform, which is arranged in the hole determined by guiding piece, which has outer surface, to determine in platform Depth between outer surface；Cure at least a portion of first layer curable powder, to determine the first solid area；Flat Relative motion is carried out between platform and outer surface, to increase the depth between platform and outer surface；By the curable powder of the second layer End is deposited in the first solid area；And at least a portion of the second layer is solidificated in the first solid area, so as to true Fixed second solid area.

Additionally provide manufacture system.The system suitably includes：Guiding piece, which has outer surface, and determines and draw Guide hole；Platform, the platform have upper surface, which is arranged in hole, and can be moved compared with guiding piece in the hole；Supply is held Device, the supply container are used to accommodate powder；Transfer device, the transfer device are arranged to pass to dusty material from supply container Bullport；Powder removing device, the powder removing device are arranged to remove powder from the platform being vertically movable；And radiation Source, the radiation source are located towards platform and apply radiation.

Implantation piece is additionally provided, which is mounted on the bone of bottom, should to provide stability to bottom bone Implantation piece includes：First area, the first area are arranged to be attached on the bone of bottom；And second area, the second area cloth It puts near first area, which has a flexibility than first area bigger, and the second area and first area are into one Body.

Description of the drawings

The general introduction of front is better understood with when read in conjunction with the accompanying drawings and below to the implantation piece and method of the application Preferred embodiment detailed description.In order to illustrate more material implantation pieces that integrate of the application, illustrated in attached drawing preferably Embodiment.However, it is to be understood that the application is not limited to precise structure shown in the drawings and means.In attached drawing：

Figure 1A -1B illustrate the multiple side views and vertical view for the manufacturing method for being used to form implantation piece according to one embodiment Figure；

Fig. 2A -2B illustrate maker and multiple views of material storage means；

Fig. 3 A-3D illustrate maker and multiple views of material storage means；

Fig. 4 A-4Y illustrate the non-limiting examples of manufacturing method；

Fig. 5 A-5C illustrate optional manufacturing method；

Fig. 5 D-5F illustrate the layer 1516,1514,1512 of the body length along Fig. 5 C；

Fig. 6 A-6B illustrate optional manufacturing method；

Fig. 7 A-7E illustrate an exemplary fabrication process；

Fig. 8 shows according to the first advantageous embodiment of the invention, the section view of the bone plate with integrated poly-material structure Figure, the plate are mounted on bone；

Fig. 9 illustrate the second preferred embodiment according to the present invention, there is the sectional view of the bone plate of integrated poly-material structure, The plate is mounted on bone；

Figure 10 illustrates the side view of the bone connection implantation piece of third preferred embodiment according to the present invention, bone connection implantation Part is mounted on bone；

Figure 11 illustrates the side view of the bone plate of the 4th preferred embodiment according to the present invention, which is mounted on bone；

Figure 12 illustrates the side view of the intramedullary nail of the 5th preferred embodiment according to the present invention, which is mounted on bone On；

Figure 13 illustrates the enlarged side view of the plate of Fig. 8；

Figure 14 illustrates the sectional view of the bone connection implantation piece of the 6th preferred embodiment according to the present invention, bone connection implantation Part is mounted between two bone sections；

Figure 15 A illustrate the top view of the bone connection core alternative of the 7th preferred embodiment according to the present invention；

Figure 15 B illustrate sectional view of the bone connection core alternative of Figure 15 A along sagittal plane；

Figure 16 A illustrate the implantation piece for including multiple material areas；

Figure 16 B illustrate the implantation piece for including multiple material areas；And

Figure 17 illustrates the implantation piece for including multiple material areas.

Specific embodiment

It should be known that the invention is not limited in special device described here and/or shown, method, application, condition or Parameter, and term used herein is intended merely to illustrate specific embodiments by example rather than limit claimed sheet Invention.In addition, in the description（Including accessory claim）, article form " one ", "the" include it is multiple, be related to special number Value includes at least particular value, unless other clear explanation herein.Terminology used in this article " multiple " means super Cross one.When representing a certain range of value, another embodiment is included from a particular value to another particular value.Similar, when When value is expressed as approximation（By using the word " about " of front）, it should be appreciated that the particular value forms another embodiment.All Scope is all included and can be combined.

It should be known that some features of the present invention introduced in single embodiment. herein in order to clear can also It is provided in combination in single embodiment.On the contrary, the multiple features of the present invention introduced in order to clear in single embodiment It can be provided separately or be provided with arbitrary sub-portfolio.Moreover, the value being related in the range of includes in the range each A value.

The some terms used in following specification are intended merely to conveniently rather than limit.Word " right side ", " left side ", " top Portion " and " bottom " represent the direction in referenced figure.Word " inside " and " outside " refer to be respectively facing and away from device and The direction of the geometric center of its component.Word " front ", " below ", " above ", " following ", " side ", " centre ", " sagitta of arc ", " axial direction ", " coronal ", " head ", " tail " and correlation word and/or phrase refer to the optimum position of referenced human body And it orientation rather than is limited.

The some terms used in following specification are intended merely to conveniently rather than limit.Word " right side ", " left side ", " under Portion " and " top " represent the direction in referenced figure.Word " inside " or " distal side " and " outside " or " nearside " refer to distinguish Toward and away from implantation piece and the direction of the geometric center of its component.Word " front ", " below ", " above ", " under Face ", " side " and correlation word and/or phrase refer to the optimum position of referenced human body and orientation rather than are limited System.Term includes the word of above-mentioned word, derivative words and the similar meaning.

The method for introducing manufacture component first.These methods are introduced with reference first to exemplary plot 4A-4Y.

First layer curable powder 1420 can be deposited on platform 1410 by user（Such as piston）On, 1410 cloth of platform It puts in the bullport 1412 determined by guiding piece 1404, which has outer surface 1406（The outer surface can also be It is characterized as upper surface, wheel rim or edge）, to determine the depth 1414 between platform 1410 and outer surface 1406.Such as attached drawing Shown in, people can be by first layer curable powder（Preferably include a large amount of particles）It is deposited on platform, and causes first At least a portion of layer curable powder cures, to determine the first solid area.User can be carried out in platform and outer surface Between relative motion, to increase the depth or distance between platform and outer surface；So that second layer curable powder sinks Product is in the first solid area；And at least a portion of the second layer is solidificated in the first solid area, to determine the Two solid areas.This method will be introduced with reference to non-limiting attached drawing 4A and 4B first.

These drawings do depict device 1400, which includes platform 1410, which has outer surface 1402 （The outer surface 1402 is also described as upper surface）, which is arranged in guiding piece 1404, which determines hole 1412 and outer surface 1404, the outer surface have edge 1406.In the non-limiting examples, platform 1410 can be characterized by living Plug, the piston have bar 1406, which can be used for so that platform 1410 moves.

Platform can be moved by applying machinery, electromechanical, hydraulic pressure or even magnetic force.For causing the side of platform movement Formula is known in the art.The edge of platform 1410 is suitably fitted close or seals with hole 1412（Such as pass through washer）.Such as figure Shown in, the outer surface 1402 of platform can be positioned at below the edge of piston component or wheel rim 1406 at certain distance 1414. In some embodiments, the outer surface 1404 of guiding piece 1404 is characterized in that as upper surface.

Guiding piece can include wheel rim 1406, which may be considered a part for outer surface 1404.Although circle Shape platform is for representing claimed invention, but platform must not necessarily have rounded face.Platform can be circular, square Or polygonal shape.

Platform can be the outer surface 1406 that can be positioned to more than guiding piece 1404.Platform, which can also be, to be positioned to So that the material being arranged on the top of surface 1402 of platform 1410 is more than the outer surface 1406 of guiding piece 1404 and exposes.As here Other parts described in, so exposure allows users to brush away what may be supported on the top of platform 1410 or by the platform 1410 Excess stock, such as Fig. 4 P（Extra powder is removed by brush 1460）And 4Q（Extra powder is removed by vacuum 1470 End）Shown in.

Being deposited in Fig. 4 C and 4D for first curable powder layer represents.As shown in these figures, one layer of powder 1420 is heavy Product is on the top of the upper surface of platform 1402.This layer of powder is preferably highly approximately equal to one of first layer curable powder The thickness of grain, although the layer can be thicker.As shown in fig.4d, powder bed can cover the entire upper surface of platform substantially 1402, although and need not be completely covered.

Suitable powder actually includes arbitrary curable materials.The powder of polymer, metal etc. all properly considers.One layer Powder can be basic monodisperse powder or polydispersion powder.For example, one layer of powder can include the monodisperse group of PEEK particles Body.First, second or this two layers of powder can be monodisperse or the powder of polydispersion-any layer can be monodisperse or polydispersion 's.Any layer of powder can also include the mixture of two kinds of materials（Such as two kinds of polymer）.

Also may be selected, layer can include the PEEK particles of different size/size.One layer of that can include two kinds of materials Grain, such as PEEK and metal.Particle can be different from each other in terms of size and/or material.Think polymer beads（Such as The particle of PEEK, polyethylene etc.）It is especially suitable.Metallic particles such as stainless steel is also suitable.

Powder can essentially be any materials.The non-limiting list of dusty material includes：Steel（Ordinary steel and stainless steel）、 Steel alloy, aluminium, titanium（And titanium alloy）, PEEK, polyethylene, other polymer etc..Given particle itself can include it is a kind of, two kinds Or more kind material.For example, given particle itself can be the mixture of two kinds of polymer and/or metal.For example, individual particle Itself can be mixture or alloy or two kinds of metals.The material that can be melted or weld together is considered especially suitable.It closes The particle size of suitable dusty material is from about 0.005mm or even about 0.01mm to about 0.1mm, 0.5mm or even 1mm Or in the range of 2mm.Particle size distribution can be set by user according to its needs.

User can also carry out selection fusing application.In the sample instance for PEEK, processing chamber housing and powder will heat To the fusing point close to PEEK（Such as 350 degree）, beam will be only so that the final energy needed for PEEK fusings introduces.Except PEEK Outside, the version of this method can be used for a variety of materials.For example, user, which can apply distinct temperature, continues specific time, So as to only so that applying some curings of powder.In this way, a part of material that user selectively can only allow to carry out processing melts Change（So as to solidify afterwards）Or fusion.For example, working space can be heated to being sufficient so that the polymer powder applied by user Cure but cause the not cured temperature of metal powder applied.

For handling the optimum condition of Special Category powder by the needs depending on powder and depending on user.For PEEK Powder, it is believed that suitably energy is about 40W, and sweep speed is about 1500mm/s, and focus is about 0.1mm diameters.It is right In powdered steel, it is believed that suitably power is 200W, and sweep speed is about 1000mm/s, and focus is about 0.15mm diameters. Optimal power applications will be depending on the needs of user and the feature of material to be processed.It is believed that suitably（It but need not It needs）The first cured layer is cooled down before forming the second layer on first layer top.Particularly, before applying and handling the second layer, the One layer of curing long period.

It can include two kinds of particles to the powder of given layer, which can be different materials.Two kinds of materials in one layer Weight ratio can be from about 10000:1 to about 1:10000 or from about 1000:1 to about 1:1000 or from big About 10:1 to about 1:10 or even about 1:1.The best ratio of a kind of material and another material is by the need depending on user It will；Given powder bed can include two kinds, three kinds, four kinds or more different materials.In one layer（Such as including different sizes In the layer of particle）The quantity ratio of different sized particles can essentially be arbitrary ratio.

In some embodiments, first layer 1420 is initiation layer, in this way, the first deposition step is included the direct cloth of first layer It puts on platform.In other structures, first layer 1420 is deposited in by platform supports, prior cured solid area.

Fig. 4 E and 4F illustrate at least a portion for curing first layer curable powder, to determine the first solid area. Curing is by applying energy from source 1430 at least a portion of the first powder bed 1420（Such as it radiates）1432 is suitably real It is existing.Applying energy suitably causes the part of this layer 1420 to become the first solid area 1440.Energy source can be laser, Maser, infrared emitter, UV ray radiation source or other radiation that the powder can be cured.User can be with Use heating fluid（Such as gas）As energy source.The object of heating（Such as plate, stylus or the pressure for forming figure of heating Mould）It is also used as suitable energy source.Electron beam, plasma beam, proton or other particles beams are also suitable energy source. Ultrasonic wave can also be applied, to adjust or to influence to melt in other ways and cure；Vibrational energy or power can be applied, to remove Remove no cured powder.As shown in Fig 4 F, user can only cure a part 1440 for the first powder bed 1420.

User can actually by powder curing into any figure-as described in other parts here, user can by Relative motion is carried out between radiation source and this layer of powder and realizes special curing figure.For example, source 32 can move to platform Then specific position above 1410 applies radiation 1432 to by the material of the platform supports.Source 1432 can apply radiation, together When moved between two or more positions, to realize the line of curing powder.

In an alternative embodiment, 1432 remains stationary of source, platform 1410 is compared with the source movement.User is also possible that source 32 and platform 1410 all move relative to each other.Source can translate in an x-y plane, can also be moved along z-axis line.Source can be set Vertically apply radiation into the surface 1402 with piston 1410；The source can also be arranged to angularly apply with surface 1402 Add radiation.

User can also realize curing figure by being inserted into mask between radiation source and powder bed.To the first powder bed Applying radiation being solidified to form one layer material 1440 is fully cured due to the first dusty material.

Beam can apply in many ways.In some instances, the welding at the exterior contour of part（Cure Region）It can be weakened by the welding at the inside parts.Increase distance between externally and internally welding can carry Height is in intrinsic inclination machinability, and welding exterior contour will improve inclined machinability after interior welds. In some embodiments, the material property improved is also caused from the outside of part towards the welding of the order of inside parts.In some feelings Under condition, when welding access is not adjacent to each other, narrow focal point can generate a suboptimum being arranged sequentially in above another Welding growth.Even when welding access is close to each other, similar effect is also generated under higher energy level.

In some embodiments, user can carry out relative motion between platform and the outer surface of guiding piece, to increase Depth between platform and outer surface.This represents that Fig. 4 I and 4J are illustrated in platform and guiding piece in Fig. 4 I and 4J（For Mark）Between relative motion cause to generate distance between the top surface of the outer surface of guiding piece and solid material 1440 1414.The relative motion can be moved and/or by guiding piece by platform 1410 compared with guiding piece 1404 1404 move compared with platform 1410 and are realized.

Then, second layer curable powder can be deposited in the first solid area by user.This is represented by Fig. 4 K.Such as this Shown in figure, second layer curable powder 1450 is deposited on the top of the first solid area 1440.Second layer curable powder Thickness is suitably approximately equal to the thickness of a particle of second layer curable powder, although the layer can be than the thickness more It is thick.

In one embodiment, the distance 1414 between the outer surface of guiding piece and the upper surface of solid material 1440 is near Approximately equal to（Or less times greater than）The thickness of one particle of second layer curable powder, in this way, can in the second curable powder It, can be by using sweeper or wiper after being applied on recessed solid material 1440（It is not shown）And remove it is extra The second powder, which leaves one layer of second powder of the height with distance 1414.

In such embodiments, once user causes one layer of curable powder（The layer can be first or initiation layer powder End）Cure, user can be so that platform advances up.Thus the region of curing powder can be caused to ramp up, so that User can be by brush, vacuum suction, by precipitation or pass through other removings or collect the sides of powder or particulate matter Method removes any uncured or extra powder.

Platform can raise sufficient amount（Such as the height for the powder bed about having been cured）, so that cured powder Region only exposes the wheel rim higher than piston hole substantially.The powder bed of substantially 0.03mm to 0.1mm thickness is achieved in that, i.e., by Region to be processed moves downward such amount, then applies powder（As shown in Fig. 4 G, 4I and 4K）Although by appropriately selected Particle size and the movement by suitable adjustable platform can also form the powder bed less than 0.03mm or more than 0.1mm.Powder The optimum thickness of layer can depend on the needs of user and processing limitation, and powder bed can be in several millimeters of several points （fractions of mm）In the range of in the range of millimeter.

Then, as shown in Fig. 4 M and 4N, user can cause at least a portion of the second layer to be solidificated in the first solid area On domain, to determine the second solid area.The curing from source 1430 to the second layer 1450 suitably by applying radiation 1432 And it realizes.Then, radiation is so that at least a portion of the second layer 1450 is transformed into second on the first solid area 1440 top Solid area 1452.As shown in the top view of Fig. 4 N, can be cured with cured first area 1440 top on generate from The second scattered powder curing region 1452.The uncured particle of second powder 1452 can be retained in the first solid area 1440 On top.Curing can cause the second solid area and the first solid area to fuse；In some embodiments, such fusion can be with It is characterized as being sintered or even weld.In some embodiments, the powder of adjacent layer is mutually bonded.This may be in adjacent layer To be generated at the position of same or like material.It is also an option that material so that a part for a material layer diffuse to it is adjacent In layer.

In some embodiments, a part for an adjacent layer can be with physical integration into adjacent layer.This can be so Position generate, in this position, first layer be it is porous or have a superficial roughness, the part of the second layer and first layer this A little features are integral.Such as attached drawing（Such as Figure 16 A）Shown in, material layer can also be configured to such a region 1202 with it is another One region 1204 is assembled together.

User can actually cause powder curing into arbitrary graphic；Column regions shown in Fig. 4 N are exemplary. Consolidation zone can be circle, polygon, square or other shapes.In a kind of version, user can cure O shapes The powder of ring, and remove the uncured powder at the ring center.Then, in addition user can be formed on the top of first ring O-ring, to generate open tubular column.It the inside of column can liquid filling body or other materials when needed.

The present invention can be also used for generating the body for including internal void space.For forming a kind of side in such gap Method is so that first layer powder curing.User cures second layer powder on the top of this layer, but is left in the second layer more A hole.Then, user can remove workpiece, then the workpiece is arranged in face-down on the top of another layers of solid material, and Continue to form the device.Again so that hole in the second layer is capped, so as to form the body for being wherein disposed with gap.

Workpiece（That is the body made of curing powder）It can be in processing procedure（It is not shown）Movement rotates or with it Its mode manipulates.In this way, user can generate the body for being of virtually the arbitrary characteristics extended along any direction.For example, with Family can generate cube by curing one or more dusty materials of pantostrat.Then, user can generate vertical from this The protrusion that first face of cube is stretched out（Such as tip）.Then, user causes workpiece to rotate, and from cube（It is not shown）It is another The second protrusion is formed on one side.

Gap arrangement can be used in the body so that body has specific physical, for example there is the skies in body Gap can generate rigid smaller and more flexible body.Gap can be also used for comprising reagent or drug, so as to by this material Storage is in the body.Gap can be also used for comprising can cured material, such as monomer afterwards.For example, such implantation Part can be introduced in body, and after pickup, the monomer being arranged in implantation piece can be cured by applying appropriate energy.Body It can also include the region comprising uncured powder（Usually in inside）.Such body can be implanted into, intrinsic not solid Changing powder can be cured by applying appropriate radiation afterwards.

User can also leave uncured region to generate such body by the edge of the layer in composition body, should Body has surface that is recessed, porous, coarse or having other feature.The surface can be used for promoting bone or other tissues inwardly raw It is long.Such surface can also be coated, because coating can have improved covering effect or the adherency to heterogeneous surface Property.

After solidification, piston can move upwards again, as shown in Fig. 4 O.So doing can be by the second powder bed not Curing powder 1450 take to allow the powder carry out it is inswept, be sucked by vacuum, brush away, blowing away or in other ways from workpiece The position of removing, as shown in Fig. 4 O, 4P and 4Q.Powder suitably removes after curing materials region is formed, and then, removes Go powder that will determine first, second or other solid area.

As described in the other parts of this paper, the relative motion between platform and outer surface can cause the first solid area Domain and/or the second solid area（Or any other solid area）Increase to over outer surface or equal with the outer surface. In Fig. 4 P, there is the powder area 1450 between consolidation zone 1452.Piston can advance up, so that powder 1450 exposes Above the surface of guiding piece.Brush 1460 or vacuum 1470 can be used for removing extra powder 1450.User can also make With electrostatic, hair-dryer or the other appropriate methods for removing powder.

Fig. 4 R illustrate the consolidation zone 1452 on the second consolidation zone 1440 top, wherein having removed extra powder （It is not shown）.Fig. 4 S illustrate the top view of consolidation zone 1452.

Then, piston area can translate downwards, as shown in fig. 4t, in this way, the edge in the top of solid structure and hole 1406 are substantially flush（It is i.e. equal）.Then, third layer powder（As shown in Fig. 4 U）It can introduce, to fill in curing area In space between domain 1452.This is represented that Fig. 4 T illustrate filling to the third layer powder in these spaces by Fig. 4 T（3rd The height of layer powder 1420 is not shown）.More layers powder（It is not shown）It can apply and be handled；These layers can be stored in In the independent container of their own.

Then, third layer powder is cured by applying energy 1432 from energy source 1430.This generates the second material Consolidation zone 1452, which is effectively embedded into a cured 3rd powder bed 1440a.In this view, exist First is identical with the powder in third layer, but arbitrary two layers of body and need not be identical.

This also represents that Fig. 4 X illustrate the vertical view for the consolidation zone 1452 being present in cured layer 1440a in Fig. 4 X Figure.4Y is the body sectional view carried out in Fig. 4 W, illustrates first layer 1440, the consolidation zone and material of the second material 1452 Bed of material 1440a, cured second material 1452 are arranged in material layer 1440a.

Powder can be provided from supply container.In the processing for using multiple material, each material can be stored in individually In supply container.For example, the first powder can be stored in the first supply container, the second powder（Such as another layer of powder Material）It is stored in second container.Other powder storage is in the container of their own（For example, the 3rd powder storage exists In 3rd supply container, the 4th powder storage is in the 4th supply container, etc.）.It is attached that supply container can be arranged in guiding piece Closely.

Below with reference to Figure 1A -1B, Fig. 2A -2B and Fig. 3 A-3D, such embodiment is illustrated in figure, wherein, select laser Sintering processes or similar process can be used for manufacturing various implantation pieces and other bodies, be included herein described in other parts Body.

With reference to figure 1A-1B, processing generally includes to add, quick manufacturing technology, it uses source 32（Such as laser）Come By material granule（Such as plastics, metal or ceramic powders）Fuse into the block of suitable 3-dimensional object.

Energy（Such as it radiates）Source 32（Such as laser）Scanner 34 is utilized in powder bed by controller 30 by scanning The section that is generated on 38 surface and fuse dusty material 36.After each section of component is scanned by scanner 34, Powder bed 38 reduces a thickness, and one layer of new dusty material is added by powder bringing device 39 at the top of powder bed On, and the processing is repeated, until completing component.Although laser described herein, other radiation or energy source can also For curing powder.Pusher 58 can be used for helping to apply or remove powder.System can also include controller, the control Device adjusts the application of radiation（Such as the movement by adjusting radioactive source, it generates the figure of application radiation by using mask, lead to It crosses so that workpiece motion s or their any combination）.

Controller can apply to one or more precalculated positions to be radiated.As described in other parts herein, user may Need the body or component of special construction.Then, user can generate a series of powder application and powder curing step, so as to Form suitable components.Then, user can set system or in other ways to System Programming, to implement the step of special sequence It is rapid to manufacture suitable components.As a part for this program, system can be applied to one or more pre-selection or precalculated position Add radiation.The system can also apply preselected amount and powder type, apply with radiation and energy consistent.

Two or more materials can be combined so, i.e., by the way that selectively powder is arranged in powder bed 38 or in powder The first material is fused at bed 38；Dusty material is removed from certain layer；Apply the second material powder on the layer；And according to control The guiding of device 30 and by the second material powder fusion at certain layer.Preferably, dusty material stores or is maintained at hopper 40a-e In（See Fig. 3 A-3D）, and the number of hopper is identical with the number of materials being desirable in arbitrary particular component.Hopper can wrap Containing single material or the even mixture of material.

When removing material（Specifically, the powder from powder bed 38 after by 34 preliminary sweep powder bed 38 of scanner Powder material 36）When, dusty material 36 can pass through vacuum, sweeper, electrostatic cleaner, hair-dryer, wiper or by almost Any other mechanism（The mechanism removes extra dusty material 36 from powder bed 38）And remove, in order to handle next layer of powder Powder material 36.

One embodiment includes the first dusty material 36 being deposited in powder bed 38, and causes second of powder bed 38 The cross-section office comprising the second material in part design is divided to be full of the second dusty material 36.Controller 30 guides lasing light emitter 32 Dispersed material 36 is fused into and the corresponding three-dimensional material layer of the special layers of component with scanner 34.

Mew layer with different materials 36 is arranged on the top of fused layers, and repeats the processing, final until having manufactured Component.Scanner can be used for assessment dusty material and be deposited on powder bed 38（The powder bed 38 is in guiding piece hole）On powder The state of powder material, the state can be used for adjusting radiation, the application of ion or other energy to powder again.As shown in FIG., Powder can be supplied by two hoppers；Two, three or even more hoppers can also be used.With single powder source （Such as hopper）Embodiment it is also suitable.

In infinite Figure 1A -1B and Fig. 2A -2B, powder supply platform（Powder supply platform could be provided as living Plug）It is arranged at height about identical with powder bed.In such a configuration, powder is then inswept from supply piston supply Or powder bed 38 is passed in other ways, to be handled.This not necessarily must because powder can be from being arranged on hopper The source in face supplies.In such embodiments, powder is arranged near powder bed, then passes through blade, spoon, sprinkler, wiping It wipes device etc. and passes to powder bed.Powder can also be arranged in a certain distance from powder bed（Such as several millimeters, several centimetres）Place, so After supply powder bed.

Suitably also it is useful for the device for spreading to powder on workbench and the device for removing excessive powder. In one embodiment, system includes blade（Or scraper）39, the blade 39 is so that powder is deposited on the forepart of wiper, the wiping Wiping device can the form into blade, the form into brush or the even form of blade and brush.Deposition can come from single only Found container or from one group（That is a row）Other containers（Each include different dusty materials）A part single appearance Device.System can be arranged to only in powder of arranged in front or more than one in the arranged in front of wiper of wiper Powder.Wiper can be also used for removing extra or undesirable powder.Although some attached drawings illustrate powder across whole A platform is spread across entire another supporting course, but this not necessarily must.User can cause powder only across platform or A part for supporting course is spread, and system can be arranged to realize this distribution.

As described elsewhere herein, ultrasonic wave or other vibrations can be used for generating flat powder bed.It can recognize Suitably to ensure that powder is present at the edge or wheel rim of guiding piece；When there is no enough powder at wheel rim, then Apply energy may simply heating wheel rim, and adjacent powder may not be heated, because no powder absorbs heat.Therefore, Dense powder distribution helps to implement these methods.Also may be selected, comparative high temperature in the processing chamber can reduce Temperature gradient in material to be processed；For example, user can apply powder, and before the powder is handled the powder is waited to reach To specific temperature.User is also conceivable to the variation in the section in the different layers of constituent part, because processing first layer powder institute The energy needed may be with handling the second layer（Adjacent first layer）Energy needed for powder is different, which can have and the Even there is the material different from first layer in one layer of different section.

Powder can also be injected or sprayed into the air of processing chamber housing, then can be fallen（Such as similar to snowflake）It is wanting On the region handled.In other embodiments, powder can be dispersed in conveyor belt, for being dispersed to workbench On.Belt can be while powder be distributed in processing chamber indoor sport.

With particular reference to Fig. 2A, some dusty materials 36 may not fit through 34 place of common laser source 32 and scanner Reason.These sensitive dusty materials 36 can use low energy measuring mechanism（Such as blue-light source or other light sources 42）To fuse or handle. In such a configuration, according to handling which kind of material, controller 30（For clarity, not shown in Fig. 2A）Guide lasing light emitter 32nd, scanner 34 and/or blue-light source 42 fuse or handle through precipitation equipment 39 to be deposited on special in powder bed 38 （desperate）Material.

Precipitation equipment can move into bar, blade or wiper that powder is passed to powder bed 38.Manufacture may need To carry out curing powder using the different-energy of two or more.For example, system can use the energy of the first kind（Such as The laser emission of one wavelength）The powder of the first kind is fused, then using the energy of Second Type（Such as second wave length is sharp Light radiation）To cure the powder of Second Type.Energy source can be adjustable；System can also include multiple energy sources.

In some embodiments, when handling metal or ceramic powders 36, fused usually using high power laser source 32 Material, and when the more sensitive material of processing（Such as polymer powder materials）When, blue-light source 42 can be used.Blue-light source 42 is not It is limitation, and substantially any light source can be included, such as ultraviolet light or infrared light sources, it fuses or handles special powder material Material, to form final component.Furthermore, it is possible to using the electrostatic precipitation of dusty material come processing component.

As shown in Figure 1A -1B and Fig. 2A -2B, hopper or powder container can be pistons, and the piston is adjacent or close to powder Last bed 38（Also referred to as platform）.Wherein arrange the top in the hole of powder container piston（As shown in Figure 1A）It can be with wherein arranging Powder bed（Or platform）Hole top it is concordant or substantially planar.This allow users to it is inswept, blow or in other ways Powder is transferred to from powder container in powder bed.

System shown in Figure 1A -1B and Fig. 2A -2B can be arranged to operate in a coordinated fashion, wherein, when system is consolidated Change specified rate powder in powder bed, during to form solid area, opposite with next layer of powder of platform to be applied to Powder container in platform move into powder transfer device proper amount of powder be provided.It is handled in this way, working as in powder bed During previous amount of powder, system prepares the amount of powder of supply next time.As described in other parts herein, powder can be by Device for removing excessive powder from the bed after the curing step passes to powder bed.

As an example of these relevant treatments, the first hopper can distribute powder, which reallocates to powder bed （Platform）38.When the powder curing on powder bed top, the second hopper prepares to distribute to the second powder of powder bed.It is extra Powder removed after solidification from powder bed 38, powder bed causes distance to be incremented by, in this way, the second powder can be distributed to solid On the top for the first powder changed, to form the layer of individual particle thickness.

With reference to figure 3D, for storing dusty material 36, these dusty materials 36 are used to be deposited on powder multiple hopper 40a-40f To handle on last bed 38.Hopper 40a-40f can be used for mixing material, highly elastic material, use of the storage for transitional region In the rigidity of formation body or the metal powder of hard portion or the almost any materials for manufacturing proper product can be suitble to.Knife Piece 39 or other devices（Such as wiper, scraper）It is suitable for powder passing to powder bed.Supply container can be actually It is arranged in arbitrary position relative to each other；They can be one by one or even relative to each other.

The needs that can be sized to meet user of powder bed.The width of bed can at several millimeters, several centimetres or more In big scope；Exemplary bed has the sectional dimension in the range of about 10mm to about 500mm（Such as width）.Bed can be with For circle, polygon, avette or be the arbitrary shape that user may need.Bed can also include（It is not shown）Insert or Overlap（In a manner of biscuit knife or template）, the insert or overlap masking bed a part, so as to change platform cut Face.For example, the platform with about 1cm radiuses can be Chong Die with bread cast template, which has the major radius and about of 1cm Inside " hole " radius of 0.5cm.Internal " hole " can be circular, square or actually any other shape.

Powder, which supplies piston and powder bed, can actually be arranged as arbitrary structures.As shown in example in Fig. 3 D, powder supplies Powder bed can be surround to piston 40a-40f（Or platform）38 arrange.In other embodiments, central powder supply piston can To be surround by powder bed.Powder supply piston can be in side there are two powder bed, in this way, blade or wiper can be with reciprocal Motion mode operates, to send powder to the bed from supply piston.

Fig. 5 A-5C illustrate the various embodiments of the method.In fig. 5, body 1500 can be by from one end of body It is formed or " composition " to the section 1502 of the other end.This causes to manufacture the body by curing multiple relatively small sections. Alternative embodiment represents that Fig. 5 B are illustrated constructs this using less and bigger section 1502 bottom-up in figure 5B Body 1500.If the construction in Fig. 5 A may spend additional time, because must be configured into multiple independent sections.According to the construction of Fig. 5 B It can more rapidly, since it is desired that less cut into slices, although the section of bigger may have more variation possibilities in some cases. Therefore, in some embodiments, the design of part vertically oriented may be than the design of part that is oriented in horizontal structure It is slower.It can but be changed according to the needs of user, treatment conditions and setting, and some users may be found that and be suitble to determine than horizontal Vertically-oriented body is quickly formed to body.

Fig. 5 C illustrate one embodiment, wherein, component is formed at a certain angle.As shown in FIG., people can be formed The layer 1512,1514,1516 in section is changed along body length, to form final products.First（Lower part）Layer 1512 includes First material 1510a, such as body is caused to have rigid metal.Interlayer 1514 includes plastics or other flexible material 1510b, So that body has some flexibilities.Upper layer 1516 could be formed with two kinds of materials 1510b and 1510a.

In this way, this method can generate the object in the section that can change with size and/or material.It is such as other herein Described in part, layer can have area of section different from each other, and therefore, this allows users to form body at a certain angle, example Such as the body of Fig. 5 C.Reducing the structure of the contact area between the component and platform surface of formation will be considered especially suitable； Can also use needs the continuously method with the structure of relatively large layer.

The exemplary method for applying radiation represents in figures 6 a and 6b.Fig. 6 A are illustrated through laser（Or other radiation Source）Beam 1632 moves to the different position on powder 1604（To cure appropriate area）And form cured powder area 1606. Energy can be applied with point, pulse, line or other structures.Also may be selected, energy can be continuously applied, while beam motion, with Just curing or the sealing wire of material are generated.Energy is suitably provided by device 1630, such as laser, maser Deng.Powder 1604 is arranged on the upper surface 1600 of piston 1602.Energy source can suitably be moved along at least one direction； The source that is moved along x, y and z direction and can inclined source it is also suitable.

User can also use mask 1608, only guide those suitable positions into radiate, as depicted in figure 6b.At this In attached drawing, mask-placement is between energy source and target powder layer, only to irradiate the specific region 1606 of powder bed 1604.It covers Mould can actually form figure in any way, this is again so that user can actually form the curing powder of arbitrary graphic. Mask can have hole 1610 formed therein, straight line, curve etc..As shown in the figure, mask is suitably for the radiation of application It is opaque.Preferably, mask can be located so that hole stops what is applied by radioactive source along the upper surface direction of movable platform At least a portion radiates.

In some embodiments（It is not shown）In, user can help to apply the powder being followed by subsequent processing using mask. In this embodiment, mask or template can be arranged on the surface top that support one layer of powder.Then, user applies powder again End, the powder will only cover surface, those parts for not blocked by powder.The thickness of template can be with one layer of suitable powder Individual particle thickness it is approximate.In operation, user removes any extra powder, and residual powder is cured（This can be It is carried out in the case of being with or without template in place）.This method can form the feature with fine-resolution.In some implementations In example, the feature with 0.05mm or more large-feature-size can be formed；Finer feature can also be manufactured.

Fig. 7 A-7E illustrate another non-limiting examples.Fig. 7 A are illustrated is arranged in workpiece by powder（Similar to Fig. 4 R's Workpiece）On top.Powder 1750 is arranged on the top of the surface characteristics 1752 of the workpiece on piston and between these features.Table The powder bed 1740 that region feature 1752 can be arranged in prior cured pushes up upper or other materials（The material connects itself with piston It touches）On top.As shown in fig.7b, then user can be solidificated in knot by applying energy 1732 to the special area of powder bed Structure（Therefore the structure is extended）Powder on top, without curing the powder of arrangement between structures.The result of this method is being schemed Represented in 7C, which illustrates the upper surface 1402 of piston 1410, the upper surface 1402 have it is at the top of them, have can consolidate The excessive powder 1750 changed the structure 1752 of powder 1760 and be arranged between these structures.Then, by being applied from source 1730 Add energy 1732 and cause powder curing.By repeating these steps, user can generate and grow what is stretched out from workpiece surface Structure 1752.Identical with other embodiments, excessive powder 1750 properly removes, should as shown in the difference between Fig. 7 D and 7E Fig. 7 D and 7E illustrate that powder 1750 is removed from the upper surface 1402 of structure 1752 and piston 1410.

Structure may be also constructed in this way, wherein, at least a portion of cured material can selectively timing afterwards It removes.For example, user may be constructed the cylindrical body with expendable material fillet, which crosses the diameter of body Extension.Once remove these expendable material items（Such as pass through etching）, user, which leaves, to be had across the hole of cylindrical body diameter Cylindrical body, the hole is corresponding to expendable material item with front position.

In some instances, deformation or undesirable feature may be formed in component in construction process.In not office In the case of being limited to any particular principles, it is believed that deformation may be the temperature ladder due to being formed in the fabrication process in component Degree.In order to solve these deformations, processing chamber housing can be heated, to reduce in component block and the component for wanting welding or sintering Temperature gradient between part.

In some cases, user can form the component that include sacrifice part with selected as, when component is completed or Before component use, which will remove.This can into behavior in this way, so that due to piston or flat surface and with the face Mechanical interaction between the component part of contact and the deformation that generates are included in the sacrifice part of component.For example, user It may want to form the implantation piece body that length is 10cm.At this moment, user may be constructed body of the length for 12cm, and remove this Body, in the fabrication process closest to the 2cm parts of piston or flat surface.

In this way, user can design such component, wherein, component, defect may be included（Or it must include and lack It falls into）Part will remove.Body can essentially be arbitrary dimension.As an example, a diameter of about 0.5mm may be constructed Or even 1mm and screw that length is about 4mm.And it may be constructed the bone that length is several centimetres or even tens centimetres Plate.Such bone plate has the section of 5mmx50mm or 10mmx30mm or has other suitable cross-sections.

Although being not shown, manufacture can carry out in the processing chamber.Processing chamber housing may be at Essential Environment pressure, although It is also suitable higher or lower than the pressure of environmental pressure, including close to vacuum.Chamber can be full of inert gas（Including rare gas Body）.When this method for whens handling steel, steel alloy, aluminium, copper alloy, silver etc., it is believed that nitrogen is suitable working gas.When adding During work titanium alloy, it is believed that argon gas is suitable.In some embodiments, flue gas is generated by the curing of powder.Suitably remove the cigarette Gas；In some instances, flue gas may interfere with the operation that energy beam guides powder into.Suitably pass through the content of chamber （Including any flue gas）It is cycled by chamber and process filter and removes flue gas.

This method can be also used for special requirement or the requirement of response user to form implantation piece or body.For example, user It may will be in the size of suitable implantation piece and mechanical property input system.Then, system can respond the needs of user to manufacture Implantation piece.User can need the implantation piece of specific dimensions according to the fracture of special bone, and in the flexible region of specific position. Respond the needs of user, it is desirable that the system of protection can be used in manufacturing suitable implantation piece.System can be remotely controlled with doctor and connect, The doctor remotely can input fabrication order to system and be manufactured for body.In this way, people may be constructed for each patient The customization body of purposes.People can respond the particular/special requirement of clinician to form required this body.

The rigidity and flexibility of the different piece of implantation piece are certainly by the needs depending on user.In some embodiments, just Property region can have the elasticity modulus between about 90 and 250GPa.Titanium and its alloy can have the elasticity of about 110GPa Modulus；Steel and cochrome can have the elasticity modulus of about 200GPa.Flexible region can have between about 2.5 and 9GPa Elasticity modulus；PEEK has the elasticity modulus of about 3.5GPa.Modulus between rigidity and flexible region（Or other characteristics） Ratio can be set according to the needs of user.For example, flexible region can be slightly more more flexible than rigid region.Other In embodiment, flexible region can be substantially more more flexible than rigid region.In some embodiments（It is not shown）In, in flexible and rigidity Modulus between region（Or other machinery characteristic）Difference can be 1%, 5%, 15%, 50%, 75%, 100%, 300% or bigger.

Although attached drawing is illustrated carrys out stable fracture bone using the body, body is not limited to fractures. In one embodiment, body can be used for supporting and suffer from（Or it is expected that suffers from）The bone of osteoporosis or similar conditions.Body may be used also For use as implantation piece come replace bone that is impaired or removing part or all.

The body can also be provided as a component of system.Such system can include kit or other bags, The kit or other implantation pieces for including multiple and different structures, and clinician can select most suitable implantation from bag Part.

Disclosed herein is a variety of implantation pieces, body and components；Term " implantation piece ", " body " and " component " will act as identical The meaning.Described method and system can be used for manufacturing these and other component.

In one embodiment, component can include implantation piece, which will be mounted on the bone of bottom, so as to bottom Bone provides stability.For example, with reference to infinite Figure 1A -1B, such implantation piece suitably includes：First area 12a, should First area 12a is mounted on bottom bone 16；And second area 12b, second area 12b are arranged in first area Near 12a, which has the flexibility than first area bigger, and the second area and first area are integral.Join below Attached drawing is examined to be further described the body.

With reference first to Fig. 8, being integrated with includes according to the bone connector of more material medical implants of first preferred embodiment Bone plate 12, the bone plate 12 have bone fixation screw 14, so that the plate 12 is mounted on bone 16, suitably across fracture portions 15.Bone plate 12 suitably includes：Rigid element（First area）12a, rigid element 12a are generally rigid material structure by single Into plate 12 is fixed on bone 16 by bone fixation screw 14 at rigid element 12a；And composite material or flexible portion 12b, The composite material or flexible portion 12b are across fracture portions 15.

Rigid element 12a is preferably anatomically formed or is arranged to be consistent with target in other ways.Rigid element The bone contact area including being used to engage with bone 16 is also suitable is, and rigid element also suitable is relatively hard and firm, Securely to engage bone screws 14.

Rigid element 12a preferably includes hard, firm metal material, for example, titanium, stainless steel or it is other can biofacies Capacity materials, it can take the overall dimension and shape of rigid element 12a, and bear the normal work item of rigid element 12a Part.Suitable plastics, metal and even plastic-metal mixture or alloy can be used in rigid region.

Composite material or flexible portion 12b（Second area）Preferably one is formed with rigid element 12a.The second area It can include one kind or even multiple material, they cause the material property of composite material or flexible portion 12b to change jointly For as needed for designer.Specifically, composite material or flexible portion 12b can be used for having a certain range of hardness, which fits Special biomechanics characteristic for the bone 16 to be repaired, 15 type of fracture run into or other anatomy desired by user Or biomechanics characteristic.Therefore, composite material or flexible portion 12b can have relatively high hardness, so as to after fixation by bone Major section be maintained at permanent position or alignment.This change of bone plate 12 can be adapted for reconstructing surgical operation.

Composite material or flexible portion 12b can have the hardness of reduction, to repair fracture, and pass through bone 16 and fractures 15 are divided to transfer additional loads, with transferring load on the contrary, so as to stimulation of bone growth or in vertebra fixing surgical hand by bone plate 12 The vertebra for being oriented to and fusing will be loaded in art, so as to which bone uptake and limit stresses be promoted to shield.In this way, user can set this Body is most preferably to guide this muscle power to lead to or leave fracture portions, to promote optimal healing.

Bone plate 12 can be handled by etching, anodization, anode plasma chemical treatment or other coatings, example Such as electrolyte deposition or plasma spray, to improve synosteosis and the bone uptake on bone plate 12 or into bone plate 12. Surface can also be roughened by machinery or in processing procedure is manufactured, as more fully described below, in order to be attached Bone alternate material, antibiotic agents deposition or other coatings or material desired by user.

The structure of composite material or flexible portion 12b with multiple material allow designer change the composite material or The hardness and/or intensity of flexible portion 12b, so as to approach simulate bone to be processed anatomy or biomechanics characteristic or Realize that designer wishes the load balancing generated between bone plate 12 and bone.

Preferred bone plate 12 can manufacture in single stage manufacture processing, so that two kinds of materials are collectively formed in compound In material or flexible portion 12b, as more fully described below.In addition, manufacturing method includes and composite material or flexible portion 12b Integral single material or homogenous portion, such as rigid element 12a, as more fully described below.

Body 10 can be bar, plate or actually any other construction.Body can have constant cross-section or variation to cut Face.Body can include single flexible region or multiple flexible regions.Flexible region can include a kind of flexible material.Flex region Domain can include two or more flexible materials；It can be by mixture or multiple material or even independent（Such as replace）'s Material area is formed.Similar, rigid region can include single material, multiple material or even more than different materials Region.Anchoring piece 14 can be screw, nail etc..Suitable anchoring piece selects the needs according to user, such as this field skill Known to art personnel.

Herein, the transition between flexible material 12b and more rigid material 12a is expressed as discrete transition.It is not total It is to need in this way, because body（Component is also referred to as in some instances）It can also include having in two kinds of materials or two regions Between more gradual transition region.As described in other parts herein, these transition can connect one layer by forming one layer Part realizes, in the portion, continuously（It is adjacent）Layer includes slightly different material proportion.For example, first layer can include 100% metal.Next adjacent layer can be 99% metal and 1% plastics.Next layer can be 98% metal and 2% plastics, with such It pushes away, to realize gradual transition.According to desirable characteristic and the material used（Metal, polymer etc.）Feature may be employed Such gradual transition, it is formed in the material gradient between two or more regions of body.With similar fusion temperature Material can match together, to be formed in the gradual transition between material or region.

First and second regions are suitably mutually integral.Such embodiment can be integrally related to, wherein, first It is interlocked with one another in structure with second area.This is represented in Figure 16 A.In this embodiment, body 1200 includes the first rigidity 1202 and second more flexible region 1204 of region.Second area 1204 is formed so that protrusion 1206 is effective by first area 1202 It surrounds, in this way, the first and second regions are mechanically interlocked with one another.It is this mechanical interlocked in no bonding agent or mechanic anchor （Such as nail, screw etc.）In the case of realize, although these reinforcements can be used.

Figure 16 B illustrate optional body 1200, wherein, second（It is flexible）Region 1204 is entirely enclosed in first（Rigidity） In region 1201.Also may be selected（It is not shown）, rigidity（First）Region can be enclosed in flexibility（Second）In region.Figure 17 is represented A further embodiment, wherein, body 1200 includes multiple second（It is flexible）Region 1204, this second（It is flexible）Region 1204 is arranged First（Rigidity）In region 1202.

In some embodiments, the first and second regions are attached to each other by transitional region between the two regions, The transitional region includes the mixture of the material of first area and the material of second area.For example, body can be included in first Transitional region between second area, in the transitional region, first material transition of the region from 100% to 99:The first of 1 Material and the second material proportion transit to 98:2 the first material and the second material proportion, and so on.In this way, user can be with Manufacture includes gradually transitting to the body of another material from a kind of material.

When in some embodiments being cured powder, it can be melted in specific position, so as to bottom Material connects, which can be the powder bed of prior cured.This can be especially through laser beam（Such as diode pulse Fibre laser）It is realized with electron beam etc..

With reference to figure 8 and 9, in the second preferred embodiments, integrated more material medical implants 10 and 210 with according to One preferred embodiment integrates more 10 similar modes of material implantation piece to form.When causing the second preferred embodiment and first excellent When selecting the embodiment to compare, same reference numerals are for representing same parts, and prefix " 2 " is presented to particularly illustrate second and is preferably implemented The component of example.

Below with reference to Fig. 8 to Figure 15 A-15B, in the second preferred embodiments, composite material or flexible portion 212b with The composite material of first preferred embodiment or the different modes of flexible portion 12b are arranged in Fig. 8.Specifically, it is excellent second It selects in embodiment, composite material or flexible portion 212b are made of the discrete layer of the first material 222 and the second material 224（Ginseng Examine Figure 13）.Therefore, second（It is more flexible）Region can include two or more materials.As shown in Figure 9, region can also wrap Two or more subregions are included, which can each include different materials.For example, body can have rigid region 212a and Flexible region 212b, wherein, flexible region includes the band of two or more alternate different materials, as shown in 212b.One Subregion in a region can be arranged to the arbitrary graphic for being suitble to user's needs.

Equally, first（Rigidity）The structure that region can also change.First area can include one, two or more Material.First area can also include one or more subregions.For example, first area can include stainless steel, but can be with It is included in the hole formed in the titanium part of first area.First area may be also constructed to so that it includes the item of different materials Band.

First（Rigidity）Region can also include being arranged proximate to second（It is flexible）The subregion in region.For example, Fig. 8 shows Body 10, wherein, second area 12b has the rigid region 12a in both sides.Body can there are two or more flexible region, Such body has the bone of multiple fracture for treating.Body can there are three or more flexible subregion.Similar, body It can include one, two, three or even more rigid subregions.

First area and/or second area can include biocompatible material, although biocompatible property is not necessarily Palpus.As described elsewhere herein, first area is suitably used to be fixed on bone.Therefore body can include arrangement Hole in rigid region（It is unmarked）, fixed component（Nail, anchoring piece, screw etc.）It can be inserted into pass through the hole, to incite somebody to action this Body is fixed on bone.One non-limiting examples represents that Fig. 8 shows be formed through in more material implantation pieces for this in fig. 8 Hole in rigid region is come the fixing screws 14 installed.Such hole can include internal thread, so as to the complementary spiral shell with anchoring piece Line engages.SynFix systems from Synthes（www.synthes.com）It is a kind of such suitable anchor system.

Although the body 10 in Fig. 8 does not include features that, body can also determine one or more gaps, Gap, space, hole, slot or even net.These gaps can be enclosed in body.Also may be selected, these gaps can be arranged In the outside of body, such as the surface along body.The gap can be provided for the ingrown position of bone.Gap can fill Or coated with chemical reagent, such as antibiotic, growth factor, antalgesic etc..

Body can also include additional materials.For example, body can include being dispersed to the particle in body or on body（Example Such as silver nano-grain）.Robots arm, splashing device etc. contribute to introducing additional materials into the appropriate parties in body or on body Formula.A part for the outer surface of implantation piece（Or even all）It can be coated；These materials can include drug, growth Factor etc..Implantation piece can be coated in biocompatible material（Such as polyethylene）In.In this way, implantation piece can be by not fully The material of bio-compatible is formed, but can coat or be laminated with biocompatible material.

It is also not shown in fig. 8, body or implantation piece can include the feature engaged with bone.Such feature can be with It is ridge, tooth, tip, hook, annular knurl, spline etc..

Entire rigid element 212a is preferably made of the first material 222, and flexible portion 212b preferably includes multilayer the One material 222.In the second preferred embodiments, the first material 222 preferably includes relatively hard, firm, biocompatible Metal material, such as titanium, stainless steel, aluminium or optional suitable material.Second material 224 is preferably made of low-durometer material, Such as polyether-ether-ketone（“PEEK”）Or other polymer materials, these polymer materials have lower than the first material 222 hard Degree, in this way, composite material or flexible portion 12b can be made of have a certain range of hardness user（According to material group Into and arrangement of first and second materials 222,224 in composite material or flexible portion 12b）.

On the contrary, in the first preferred embodiment, composite material or flexible portion 12b are made of the first and second materials, it should First and second materials need not be simultaneously layered as described in the second preferred embodiment, but still can be used for adjusting composite wood The characteristic of material or flexible portion 12b.

The bone plate 12,212 of first and second preferred embodiments is preferably used to promote the life of the fracture portions 15 in bone 16 Object reparation.Preferred bone plate 12,212 can have that some are flexible, to bridge feature 15 and poroma to be promoted to be formed, this can with Mode biologically more more accurate than common rigid bone plate comes stable fracture part 15, such as those of ordinary skill in the art Know.Preferred bone plate 12,212 with composite material or flexible portion 12b, 212b usually can transfer attached to bone and fracture portions Loading, in this way, in healing process, any load that remodeling bone carrying at fracture portions 15 is run by bone 16 it is larger Part.

With reference to figure 9-11, the three, the 4th connected according to the present invention with more material medical treatment bones that integrate of the 5th preferred embodiment Implantation piece 310,410,510 is similar with the bone connection implantation piece 10,210 of the first and second preferred embodiments.Same reference numerals The same or like element of implantation piece 310,410,510 is connected for representing the three, the 4th with the bone of the 5th preferred embodiment, and It is useful for representing the prefix " 3 " of third preferred embodiment, for the prefix " 4 " that represents the 4th preferred embodiment and for representing the The prefix " 5 " of five preferred embodiments.

In third preferred embodiment, bone plate or bone connection implantation piece 312 are preferably bridged between two bone structures Fracture portions.Fracture can at a part for long bone 320 or can be arranged in during spinal surgery vertebra it Between interbody space in（It is not shown）.The bone connecting component 312 of third preferred embodiment includes two composite materials or flexible part Part 312b, the composite material or compliant member 312b have first and the included in the single section of bone connecting component 312 Two materials 322,324, which is roughly parallel to longitudinal axis.The bone connecting component 312 of third preferred embodiment is not limited to In including two sseparated composite materials or flexible portion 312b, and single composite material or compliant member or attached can be included The composite material or compliant member added（According to the preferred design of developer, the special bone operated or bone can be connected plant Enter part 310 and be adjusted to the other factors for being suitble to special anatomical structure or bone）.

The bone connection implantation piece 310 of third preferred embodiment is additionally included in tip or surface roughness features at opposite end 314, so that bone connection implantation piece 310 is fixed on bone.The bone connection implantation piece 310 of third preferred embodiment is not limited to Bone connecting component 312 is fixed on bone including tip or surface roughness features 314, screw, plate, bonding agent can also be included Bone connecting component 312 is fixed on bone by adhering device or other mechanisms.In addition, fracture portions can be by plate and screw Lai auxiliary Help supporting, such as the above-mentioned bone connection implantation piece 10,210 of the first and second preferred embodiments.

Implantation piece 310 may be inserted into, to connect the two of fractured bones 320 regions（It is not shown）.In this embodiment, plant Entering the end of part can be glued or be otherwise affixed on the face of fracture portions.The end of implantation piece can also be mechanically fixed （Such as pass through anchoring piece or bone screws）Ground is inserted into, so that body is held in place.

With reference to figure 11, in the 4th preferred embodiment, bone connection implantation piece 410 includes bone plate 412, the bone plate 412 with The bone plate 12 of first and second preferred embodiments, 212 similar modes cross over fracture portions 420.But, the 4th preferred embodiment Preferred bone plate 412 include across two composite materials of fracture portions 420 or flexible portion 412b.Such structure to set The part of bone plate 412 can be further adjusted to the anatomy or biomechanical characterization that are suitble to bone B to be treated by meter personnel.This Outside, similar structures can be used in three or more rigid elements 412a providing screw hole, and each rigid element 412a passes through extremely A few flexible portion 412b is separated, so that flexible portion 412b crosses over multiple fracture portions 420 in bone.

With reference to figure 12, in the fifth preferred embodiment, for bone connecting component 512 into the form of intramedullary nail, the intramedullary nail is preferred It is to be located in implant infrastructure in the intramedullary cavity passage 520 of bone 526.The preferred bone connecting component 512 of 5th preferred embodiment Including multiple composite materials or flexible portion 512b and multiple rigid element 512a, so that nail 512 and its mechanical features It is suitble to the hope of designer.Nail 512 is fixed on bone 520, the bone fixation screw 14 preferably through bone fixation screw 14 It is engaged in the both sides of marrow internal channel 520 with bone 526.

Refer to the attached drawing, the composite material or flexible portion 12b of bone connecting component or bone plate 12,212,312,412,512, 212b, 312b, 412b, 512b preferably have above-mentioned composite structure, which has restricted openings hole, this Fatigue strength can be reduced, the second material 224,324,424,524 includes polymer material（The polymer material substantially avoids One metal material 222,322,422,522 is plastically deformed）, substantially smooth, continuous first metal material 222,322,422,522 Retaining groove intensity, and second polymer material 224,324,424,524 due to surrounding the first metal material 222,322, 422nd, 522 and limit be plastically deformed.

With reference to figure 14, integrated more material medical treatment bones connection implantation piece 710 be connected with above-mentioned bone implantation piece 10,210,310, 410th, 510 is similar, and same reference numerals are used to represent similar elements, and is useful for representing the special portion of the 6th preferred embodiment The prefix " 6 " of part.

The bone connecting component 612 of 6th preferred embodiment includes tip 614 on opposite ends, and the tip 614 is for head First or initially bone connection implantation piece 610 is fixed on bone 620.The bone connection implantation piece 610 of 6th preferred embodiment is included in The various structures and material of relative narrowness rigid element 612a and composition composite material or flexible portion 612b near tip 614 Material combination.The bone connection implantation piece 610 of 6th preferred embodiment has illustrated the adaptability of manufacturing method, in composite wood Material or flexible portion 612b in multiple structures, shape and material are provided so that bone connection implantation piece 612 adapt to it is to be treated The requirement of the biology of fracture portions or bone, anatomy or totality.

For example, different materials and combination can be used in entire composite material or flexible portion 12b, so as in rigidity It is seamlessly transitted between part 12a and composite material or the high flexibility central part of flexible portion 612b or conveniently compound Other proper characteristics in material or flexible portion 612b.It is in composite material or flexible portion 612b, in rigid element 12a These regions of transition can coordinate in rigid element 612a and composite material or flexible part between high flexibility central part Divide the stress shielding between the soft core of 612b.

With reference to figure 15A and 15B, implantation piece 710 and above preferred embodiment class are connected according to the bone of the 7th preferred embodiment Seemingly, and same characteristic features are represented by same reference numerals, and are useful for representing the prefix of the specific characteristic of the 7th preferred embodiment “7”。

The bone connection implantation piece 710 of 7th preferred embodiment is formed and as core alternative.7th preferred embodiment Core, which replaces bone connection implantation piece 710, to be included：Tip 714, so that bone connecting component 712 is fixed on vertebra 720；And The core 716 of relative resilient or softness, the core 716 are preferably to simulate 730 characteristic of core of interverbebral disc.Soft core 716 is by hydroelastic Material is formed, it is also possible to the mechanical property hydrogel similar with the core 730 of interverbebral disc or other materials.

The preferable production process that will be described in greater detail below can be by relatively hard sturdy material（Such as titanium）To be formed Tip 714, and it is formed in rigid element 712a and softness by including the multiple material of composite material or flexible portion 712b Transitional region between core 716.The bone connecting component 712 of 7th preferred embodiment can be by a variety of biocompatible component materials Expect to form, they are friendly to bone, such as titanium, titanium alloy, hydroxyapatite or other as known to those of ordinary skill in the art Biocompatible material.

Body can be arranged to more flexible along particular orientation（It is or more rigid）.For example, body can be arranged to along a side To relatively easy bending, but do not allow in opposite direction flexible.This can be by arranging and being formed in body by flexible region It inside realizes, so that body has special mechanical property.For example, although the body 1202 of Figure 12 is included at body central Flexible region 1204, which can be arranged closer to the edge or surface of body, to have along a side To special flexibility.The flexibility of body（Second）Region can form triangle or even pyramid, so as to only along special Direction promotes flexible.

Figure 12 illustrates the non-limiting examples of claimed body.As shown in the figure, body 1200 can include flexibility Region 1204, the flexible region 1204 are arranged between two more rigid regions 1202.Body is configured in this way, as schemed Shown, flexible region is effectively anchored in one or more rigid regions.In the non-limiting examples of Figure 12, flexible portion into Row casting so that the flare portion 1206 of flexible region stretches out, and is anchored in the rigid region of flexible region side. Although the extension of flexible region is tubaeform in fig. 12, various structures can be used for flexible and rigid region anchor Gu together.As shown in Figure 12, a part of of flexible region can be exposed in this external environment.

Figure 12 also illustrates alternative embodiment, wherein, flexible region 1204 is contained entirely in implantation piece body 1200. In the figure, the column regions of flexible material are included in the body of bigger, and the bigger body is by rigid material 1202（Such as gold Belong to）Manufacture.This structure causes body to have some flexibilities at the position of flexible region certainly.For example, the sheet shown in Figure 12 Body can pass through anchoring piece in each end（It is not shown）It anchors, and flexible region is located in above fracture portions.

Body can be configured so that rigid material has some flexibilities（It is i.e. not fully rigid）, and in body Flexible material is compared to more rigid.In this way, with the body regions being completely contained in shown in intrinsic flexible region, Figure 12 Itself it is flexibility.

Figure 13 is the yet another exemplary embodiment of claimed body.As shown in FIG., body 1200 may be embodied in more Multiple flexible regions 1204 in rigid region 1202.Body can be with（It is not shown）Some rigidity included in flexible region Region.When user wishes that body is close to be assembled in special space（Space particularly in irregular shape）, but rigidity is also provided When, such embodiment can be highly advantageous.

System also suitable is including powder removing device, the powder removing device be arranged to from can vertical and straight movement platform Upper removing powder.As described in other parts herein, user can be advanced up by platform and expose the curing of powder Part, so as to remove extra or uncured powder.This removing can be by brushing away, being sucked by vacuum, blowing away, precipitating （Such as pass through electrostatic）, apply and magnetic force or realized by other methods known in the art.

Powder can pass to platform from powder container in many ways.In one embodiment, powder is directly from cloth The powder container on platform is put to distribute to platform；In other embodiments, powder is arranged in by one of platform supports Layer（Such as the layer having been cured）On.Then, powder can flatten, to obtain the powder bed of suitable thickness（Such as particle Thickness）.Powder can be struck off in a manner of windscreen wiper or chip scraper by using brush or wiper and realize by flattening. User can also apply vibration or be shaken to powder（Such as pass through ultrasonic wave）, in order to stabilize powder, and formed and smooth powder Layer.Vibration（Such as ultrasonic wave）It can be used for removing extra or undesirable powder after powder curing step.

As shown in Figure 1A and 1B, powder can also pass to platform by inswept, brush etc. from powder dispensing piston.This Kind is transferred and can realized by steel or synthetic material blade, which is pushed to powder above region to be processed.It can be with Using steel blade, because such blade is for relatively bulk（I.e. section is more than 4mm）Or with smaller element（Section is small In about 4mm）Particle all facilitate increase density of material.Synthetic material wiper blade, which is deemed appropriate to processing, to be had relatively Small bore（<4mm）Or the powder with smaller feature.In some embodiments, smaller particle can use relatively lower Blade/inswept speed is handled.The brush blade of steel fibre with about 0.1mm is considered especially suitable, particularly works as powder When particle may have relatively small section or the other feature less than about 4mm.Also may be used using the similar brush of synthetic material fiber To be suitable for claimed method.Brush material can in operation be reduced with selected as or avoid electrostatic.

System also suitable is including chamber, and powder-processed carries out in the chamber.Chamber can be close for external environment Envelope.System also suitable is including being used for fume treatment and/or for introducing a gas into the device of chamber or apparatus structure.Flue gas Processing system can be arranged to that flue gas or gas are removed or filtered from chamber.System can also be arranged to working gas（Such as Inert gas）Introduce chamber.

System can also include temperature control system and/or humidity control system.User can be manipulated in the indoor ring of chamber Border, to obtain optimization process.In some embodiments, system can also include picking up or being manipulated in other ways by institute State the device of the body of method formation.Such device can be used for pickup complete component, and make these components prepare into Row packaging uses.In some embodiments, device can be used for picking up work piece, and inverts or redirect work in other ways Part, for being further processed.System further includes to distribute liquid to the device in workpiece or on workpiece；It is such as other herein Described in part, body can be formed as including gap, and fluid can be distributed into the gap.Distributor can be also used for anti-corrosion Agent or other fluids（Or even gas）Distribution is into the packaging of arrangement finishing body.

Material to be processed is compared with the best orientation that any powder distributor moves by the needs depending on user.Having Have tilt down or the part of angle in, preferably（Though it is not necessary to）So that powder distributor behind inclined-plane towards this Inclined-plane dispenses powder.Powder can also parallelly be dispensed with the edge or inclined-plane for the body to be formed or even with edge into Certain angle.In some embodiments, pantostrat can be applied by the powder distributor for dispensing powder in mutually opposite directions Add.In other embodiments, pantostrat can be 90 degrees to each other by being orientated（Or 270 degree）Dispenser apply.Dispenser It can be oriented along the short axle or long axis of the body formed and dispense powder；Dispenser can also be arranged to along the axis compared with body Direction that line is at an angle of dispenses powder.

It will be appreciated by those skilled in the art that in the case where not departing from the generalized concept of the present invention, it can be to above-mentioned reality Example is applied to be changed.It is therefore to be understood that the invention is not limited in the specific embodiments, but will be covered in by this theory The version in the spirit and scope of the present invention that bright book determines.

Claims (38)

1. a kind of method for manufacturing bone connection implantation piece, including：

So that first layer curable powder is deposited on platform, which is arranged in the hole determined by guiding piece, to determine Depth between the outer surface of the platform and the guiding piece, the first layer include the first material；

Apply the energy of the first kind at least a portion of first layer curable powder, to determine the first solid area；

Relative motion is carried out between the platform and the outer surface, to increase between the platform and the outer surface The depth；

Second layer curable powder is deposited near first solid area, the second layer includes and first material The second different materials；And

Cure the energy applied with the first kind at least a portion of the second layer near first solid area The energy of different Second Types is measured, to determine the second solid area, second solid area and first solid area Domain is integrally formed.

2. according to the method described in claim 1, wherein：It is described to cure so that second solid area fusion is described first In solid area.

3. according to the method described in claim 1, wherein：The first layer curable powder includes multiple particles, the first layer The of substantially equal depth of the thickness of a particle in the curable powder particle with the first layer is determined.

4. according to the method described in claim 1, wherein：The curable powder of the second layer includes multiple particles, this second Layer has the of substantially equal depth of the thickness of a particle in the curable powder particle with the second layer.

5. according to the method described in claim 1, wherein：First layer is initiation layer, and the first deposition step is included described first Layer is directly arranged on the platform.

6. according to the method described in claim 1, wherein：First deposition step includes the first layer being deposited on by described flat In platform supporting, prior cured solid area.

7. according to the method described in claim 1, wherein：The outer surface of the guiding piece is characterized by upper surface.

8. according to the method described in claim 1, wherein：Relative motion is carried out between the platform and the outer surface to be included So that the platform is moved compared with the guiding piece.

9. according to the method described in claim 1, wherein：Relative motion is carried out between the platform and the outer surface to be included So that the guiding piece is moved compared with the platform.

10. according to the method described in claim 1, wherein：Relative motion bag is carried out between the platform and the outer surface It includes so that first solid area and/or second solid area increase to over the outer surface.

11. it according to the method described in claim 1, further includes：It removes and is curing at least a portion of first layer curable powder To determine at least a portion of the second layer of first solid area afterwards and/or on the first solid area is solidificated in so as to true At least a portion of remaining uncured powder after fixed second solid area.

12. the method according to claim 11, wherein：The removing includes brush, vacuum suction, electrostatic attraction, blows away, wipes It wipes or their any combination.

13. it according to the method described in claim 1, further includes：Before one layer of curable powder is applied so that the platform to The lower enough distance of advancing so that the individual particle thick layer of the curable powder applied substantially with the flush with outer surface.

14. according to the method described in claim 1, wherein：It is described to cure by applying radiation to realize.

15. the method according to claim 11, wherein：The radiation includes laser emission, ultraviolet radiation, infrared ray spoke It penetrates or their any combination.

16. according to the method described in claim 1, wherein：Material for the first layer curable powder is stored in first In supply container.

17. according to the method described in claim 1, wherein：Material for the first extra play curable powder is stored in second In supply container.

18. it according to the method for claim 17, further includes：Apply third layer curable powder.

19. the method according to claim 11, wherein：The third layer curable powder is stored in the 3rd supply container In.

20. according to the method described in claim 1, wherein：At least one bag in the first or second layer curable powder Include the basic monodisperse group of powder particle.

21. according to the method described in claim 1, wherein：At least one bag in the first or second layer curable powder Include the basic polydispersion group of powder particle.

22. the method according to claim 11, wherein：At least one bag in the first or second layer curable powder Include the mixture of two or more materials.

23. the method according to claim 11, wherein：The mutual weight ratio of described two materials is from 10000:1 to 1: 10000。

24. the method according to claim 11, wherein：The mutual weight ratio of described two materials is from 1000:1 to 1: 1000。

25. the method according to claim 11, wherein：The mutual weight ratio of described two materials is from 10:1 to 1:10.

26. the method according to claim 11, wherein：The mutual weight ratio of described two materials is 1:1.

27. it according to the method described in claim 1, further includes：At least a portion of first material is made to be cured to form One curing materials and at least a portion of second material is made to be cured to form the second curing materials.

28. the method according to claim 11, wherein：Second curing materials have more than first curing materials Big flexibility.

29. it according to the method for claim 27, further includes：Form first solid area and second solid area Between transitional region the step of, the transitional region include first curing materials and second curing materials.

30. the method according to claim 11, wherein：The transitional region and first solid area and described second Both solid areas are integrally formed.

31. the method according to claim 11, wherein：The transitional region has than the first solid area bigger Flexibility and wherein described second solid area have the flexibility than the transitional region bigger.

32. it according to the method described in claim 1, further includes：Third layer curable powder is deposited on described first and second Step near solid area.

33. the method according to claim 11, wherein：The third layer curable powder includes first material and institute State both second materials.

34. it according to the method for claim 32, further includes：The third layer curable powder is made to be cured to form the 3rd solid The step of body region, the 3rd solid area limit transitional region.

35. the method according to claim 11, wherein：The flexibility that 3rd solid area has（i）More than described One solid area and（ii）Less than second solid area.

36. it according to the method described in claim 1, further includes：i）After first curing schedule, ii）Described second After curing schedule or iii）At least one of the remaining uncured powder between consolidation zone is removed after the two The step of part.

37. it according to the method for claim 36, further includes：New curable powder layer is deposited to fill the curing area The step of space between domain.

38. it according to the method for claim 37, further includes：The new curable powder layer is made to be cured to form new consolidate The step of body region, the new solid area with（i）First solid area,（ii）Second solid area or （iii）The two is integrally formed.